Intention to treat and per protocol analysis in clinical trials.

Nephrology
Giovanni TripepiKitty J Jager

Abstract

In clinical epidemiology, experimental studies usually take the form of randomized controlled clinical trials (RCTs). The data analysis of an RCT can be performed by using two complementary strategies, that is according to the intention to treat (ITT) principle and the per protocol (PP) analysis. By using the ITT approach, investigators aim to assess the effect of assigning a drug whereas by adopting the PP analysis, researchers investigate the effect of receiving the assigned treatment, as specified in the protocol. Both ITT and PP analyses are essentially valid but they have different scopes and interpretations dependent on the context.

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Citations

Oct 1, 2020·Human Reproduction·Jigal Haas, Raoul Orvieto
Nov 25, 2020·International Journal of Environmental Research and Public Health·Marlijn HuitinkCoosje Dijkstra
Jun 10, 2021·Critical Care : the Official Journal of the Critical Care Forum·Fabio Silvio TacconeUNKNOWN PRINCESS investigators
Jul 21, 2021·The Journal of Adolescent Health : Official Publication of the Society for Adolescent Medicine·Gail M FergusonRachel Powell

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